Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8
About this trial
This is an interventional treatment trial for Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Eligibility Criteria
Inclusion Criteria:
- STEP 1 RANDOMIZATION: Patients must be age >= 18 years
- STEP 1 RANDOMIZATION: Patients must have histologically confirmed T1N1-3M0 or T2-3N0-2M0 esophageal or gastroesophageal junctional adenocarcinoma (Siewert I and II)
- STEP 1 RANDOMIZATION: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- STEP 1 RANDOMIZATION: Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform an esophagectomy
- STEP 1 RANDOMIZATION: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Hemoglobin (Hgb) >= 9 g/dL (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Leukocytes >= 3,000/mm^3 (within less than or equal to 14 days prior to randomization)
- STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving either carboplatin or paclitaxel chemotherapy
- STEP 1 RANDOMIZATION: Patients must have no contraindication to receiving radiation therapy
- STEP 1 RANDOMIZATION: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
- STEP 1 RANDOMIZATION: Patients must have adequate cardiac function including electrocardiogram (EKG) and echocardiogram for any patient with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs
- STEP 1 RANDOMIZATION: For patients with evidence of uncontrolled CHF, myocardial infarction (MI), cardiomyopathy, or myositis, require a cardiac evaluation and clearance including lab tests and cardiology consultation (EKG, creatinine phosphokinase [CPK], troponin, and echocardiogram)
- STEP 1 RANDOMIZATION: Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable anti-viral regimen
- STEP 2 RANDOMIZATION: Patients must have a post-operative ECOG performance status of 0-2
- STEP 2 RANDOMIZATION: Absolute neutrophil count >= 1,500/mcL (within less than or equal to 14 days prior to randomization)
- STEP 2 RANDOMIZATION: Platelets >= 100,000/mcL (within less than or equal to 14 days prior to randomization)
- STEP 2 RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to randomization)
- STEP 2 RANDOMIZATION: AST (SGOT)/ ALT (SGPT) =< 2.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
- STEP 2 RANDOMIZATION: Serum creatinine =< 1.5 x institutional ULN (within less than or equal to 14 days prior to randomization)
- STEP 2 RANDOMIZATION: Patients must be disease free following esophagectomy as is demonstrated by having no evidence of disease on a post-surgical CT scan. Patients must also have a negative surgical margin (R0 resection)
Exclusion Criteria:
- STEP 1 RANDOMIZATION: Patients may not have received prior chemotherapy or radiation therapy for management for this malignancy
- STEP 1 RANDOMIZATION: Patients may not have received prior immunotherapy for management of this malignancy or for any other past malignancy
- STEP 1 RANDOMIZATION: Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
STEP 1 RANDOMIZATION: Patient must NOT have previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions:
- Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR
- Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR
- Date of last evidence of disease
- STEP 1 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses =< 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
- STEP 1 RANDOMIZATION: Patients must not have a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Testing should be conducted to determine eligibility
- STEP 1 RANDOMIZATION: Patients must not be receiving any other investigational agents
- STEP 1 RANDOMIZATION: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
STEP 1 RANDOMIZATION: Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants from carboplatin, paclitaxel, ipilimumab or nivolumab
- All patients of childbearing potential must have a blood test or urine study done within 2 weeks prior to randomization to rule out pregnancy. Those enrolled on Arm B with nivolumab must agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of starting nivolumab to rule out pregnancy
- A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- STEP 1 RANDOMIZATION: Patients of childbearing potential must not expect to conceive children by either abstaining from sexual intercourse for the duration of their participation in the study or by agreeing to use both double barrier contraception and birth control pills or implants for at least one month prior to the start of the study drug and continuing for 5 months after the last dose of study drug. Investigators shall counsel patients of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy
- STEP 2 RANDOMIZATION: Patient registration must not exceed 12 weeks from time of esophagectomy
- STEP 2 RANDOMIZATION: Patients must not have an active, known or suspected autoimmune disease or a condition requiring treatment with steroids or immunosuppressive agents. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- STEP 2 RANDOMIZATION: Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications with 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
- STEP 2 RANDOMIZATION: Patients must not be receiving any other investigational agents
- STEP 2 RANDOMIZATION: Patients with an uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
STEP 2 RANDOMIZATION: Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risks for adverse events in nursing infants from nivolumab or ipilimumab
- All patients of childbearing potential must have a blood test or urine study done (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to randomization to rule out pregnancy. All patients must also agree to have a pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of starting nivolumab to rule out pregnancy. Those enrolled on Arm D with ipilimumab must agree to have pregnancy tests within 72 hours of each ipilimumab administration to rule out pregnancy
- STEP 2 RANDOMIZATION: Patients of childbearing potential must not expect to conceive children by either abstaining from sexual intercourse for the duration of their participation in the study or by agreeing to use both double barrier contraception and birth control pills or implants for at least one month prior to the start of the study drug and continuing for 5 months after the last dose of study drug . Investigators shall counsel patients of childbearing potential on the importance of pregnancy prevention and the implications of an unexpected pregnancy
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Cancer Center at Saint Joseph's
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- PCR Oncology
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Community Cancer Institute
- University Oncology Associates
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- Mercy Cancer Center - Sacramento
- University of California Davis Comprehensive Cancer Center
- Saint Helena Hospital
- Pacific Central Coast Health Center-San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria
- Presbyterian Intercommunity Hospital
- Woodland Memorial Hospital
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Saint Francis Cancer Center
- Porter Adventist Hospital
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Longmont United Hospital
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Beebe South Coastal Health Campus
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- MedStar Georgetown University Hospital
- AdventHealth Altamonte
- Mount Sinai Comprehensive Cancer Center at Aventura
- Holy Cross Hospital
- Regional Cancer Center-Lee Memorial Health System
- University of Florida Health Science Center - Gainesville
- AdventHealth Kissimmee
- Mount Sinai Medical Center
- AdventHealth Orlando
- AdventHealth East Orlando
- Emory Proton Therapy Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii Cancer Care - Westridge
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Luke's Cancer Institute - Twin Falls
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- University of Illinois
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Edward Hines Jr VA Hospital
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Illinois CancerCare - Washington
- IU Health North Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Reid Health
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Greater Regional Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Saint Joseph Hospital
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Jewish Hospital
- UofL Health Medical Center Northeast
- Ochsner Medical Center Kenner
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- MaineHealth Coastal Cancer Treatment Center
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Lafayette Family Cancer Center-EMMC
- Maine Medical Center-Bramhall Campus
- MaineHealth Cancer Care Center of York County
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Center- Scarborough Campus
- Maine Medical Partners - South Portland
- Tufts Medical Center
- Boston Medical Center
- Lowell General Hospital
- Saint Joseph Mercy Hospital
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Ascension Saint John Hospital
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Saint Mary's Oncology/Hematology Associates of Marlette
- Ascension Providence Hospitals - Novi
- 21st Century Oncology-Pontiac
- Saint Joseph Mercy Oakland
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Ascension Providence Hospitals - Southfield
- Ascension Saint Joseph Hospital
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- Essentia Health - Park Rapids
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Saint Patrick Hospital - Community Hospital
- Nebraska Medicine-Bellevue
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Comprehensive Cancer Centers of Nevada - Henderson
- OptumCare Cancer Care at Seven Hills
- OptumCare Cancer Care at Charleston
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- Radiation Oncology Centers of Nevada Southeast
- Comprehensive Cancer Centers of Nevada - Northwest
- OptumCare Cancer Care at MountainView
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- Comprehensive Cancer Centers of Nevada - Central Valley
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Ocean University Medical Center
- Monmouth Medical Center
- Southern Ocean County Medical Center
- Jersey Shore Medical Center
- Rutgers Cancer Institute of New Jersey
- Riverview Medical Center/Booker Cancer Center
- Community Medical Center
- Lovelace Medical Center-Saint Joseph Square
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Sands Cancer Center
- Noyes Memorial Hospital/Myers Cancer Center
- Glens Falls Hospital
- Northwell Health/Center for Advanced Medicine
- Garnet Health Medical Center
- Mount Sinai Chelsea
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- Mount Sinai Hospital
- NYP/Weill Cornell Medical Center
- University of Rochester
- State University of New York Upstate Medical University
- Novant Health Presbyterian Medical Center
- Novant Health Cancer Institute - Huntersville
- Novant Health Presbyterian Medical Center Huntersville
- Novant Health Cancer Institute - Kernersville
- Matthews Radiation Oncology Center
- Novant Health Cancer Institute - Matthews
- Novant Health Cancer Institute - Mooresville
- Novant Health Cancer Institute - Mount Airy
- Rowan Regional Medical Center
- Novant Health Cancer Institute - Statesville
- Novant Health Cancer Institute - Thomasville
- Novant Health Cancer Institute - Wilkesboro
- Novant Health Forsyth Medical Center
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- Indu and Raj Soin Medical Center
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- Kettering Medical Center
- Cleveland Clinic Cancer Center Mansfield
- Hillcrest Hospital Cancer Center
- North Coast Cancer Care
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- South Pointe Hospital
- Saint Joseph Warren Hospital
- University of Cincinnati Cancer Center-West Chester
- Cleveland Clinic Wooster Family Health and Surgery Center
- Saint Elizabeth Youngstown Hospital
- Mercy Hospital Oklahoma City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's Cancer Center - Allentown
- UPMC Altoona
- UPMC-Heritage Valley Health System Beaver
- Saint Luke's University Hospital-Bethlehem Campus
- Lehigh Valley Hospital - Muhlenberg
- UPMC Hillman Cancer Center at Butler Health System
- UPMC Camp Hill
- Carlisle Regional Cancer Center
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Pocono Medical Center
- Saint Luke's Hospital-Anderson Campus
- UPMC Hillman Cancer Center Erie
- UPMC Cancer Center at UPMC Horizon
- UPMC Cancer Centers - Arnold Palmer Pavilion
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Penn State Milton S Hershey Medical Center
- IRMC Cancer Center
- Jefferson Hospital
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Geisinger Medical Oncology-Lewisburg
- UPMC Cancer Center at UPMC McKeesport
- Forbes Hospital
- UPMC Cancer Center - Monroeville
- UPMC Hillman Cancer Center - Monroeville
- UPMC Hillman Cancer Center in Coraopolis
- UPMC Hillman Cancer Center - Part of Frick Hospital
- Arnold Palmer Cancer Center Medical Oncology Norwin
- Allegheny Valley Hospital
- UPMC Hillman Cancer Center - New Castle
- University of Pennsylvania/Abramson Cancer Center
- Allegheny General Hospital
- UPMC-Magee Womens Hospital
- UPMC-Saint Margaret
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Pottstown Hospital
- UPMC Cancer Center at UPMC Northwest
- UPMC Cancer Center-Uniontown
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Cancer Center-Washington
- UPMC Washington Hospital Radiation Oncology
- UPMC West Mifflin-Cancer Center Jefferson
- Reading Hospital
- Wexford Health and Wellness Pavilion
- UPMC Memorial
- Rhode Island Hospital at East Greenwich
- Newport Hospital
- Rhode Island Hospital
- Medical University of South Carolina
- Saint Francis Hospital
- Saint Francis Cancer Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Baptist Memorial Hospital and Cancer Center-Collierville
- Baptist Memorial Hospital and Cancer Center-Memphis
- Vanderbilt University/Ingram Cancer Center
- Saint Joseph Regional Cancer Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- UT Southwestern Clinical Center at Richardson/Plano
- University of Utah Sugarhouse Health Center
- Huntsman Cancer Institute/University of Utah
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- Norris Cotton Cancer Center-North
- University of Virginia Cancer Center
- Virginia Cancer Institute
- Virginia Commonwealth University/Massey Cancer Center
- VCU Community Memorial Health Center
- Providence Regional Cancer System-Aberdeen
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- Valley Medical Center
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- United Hospital Center
- West Virginia University Charleston Division
- West Virginia University Healthcare
- Camden Clark Medical Center
- ThedaCare Regional Cancer Center
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- HSHS Sacred Heart Hospital
- Marshfield Medical Center-EC Cancer Center
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Essentia Health-Hayward Clinic
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Essentia Health-Spooner Clinic
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Essentia Health Saint Mary's Hospital - Superior
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm A (carboplatin, paclitaxel, radiation therapy)
Arm B (carboplatin, paclitaxel, radiation therapy, nivolumab)
Arm C (nivolumab)
Arm D (nivolumab, ipilimumab)
Patients receive carboplatin IV and paclitaxel IV once weekly and undergo radiation therapy QD (Monday-Friday) beginning on day 1 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.
Patients receive carboplatin, paclitaxel, and radiation therapy as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every week for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or PET scan during screening and follow-up and undergo collection of blood samples throughout the trial.
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.
Patients receive nivolumab as in Arm C and receive ipilimumab IV over 90 minutes on day 1 of cycles 1 and 4 and day 15 of cycles 2 and 5. Treatment repeats every 4 weeks for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan and collection of blood samples throughout the trial.